Shared decision making for stroke prevention in atrial fibrillation (SDM4Afib)

 描述(由申请人提供)：慢性非瓣膜性房颤(房颤)是一种非常常见且代价高昂的公共卫生问题。房颤可能会降低生活质量和持续时间，特别是通过增加破坏性血栓栓塞性中风的风险。抗凝剂，包括维生素K拮抗剂(VKA，如华法林)和非VKA抗凝剂(NOAC，如达比卡特兰、沙班)是非常有效的治疗方法，但未得到充分利用。抗凝血使用不足的结果形成了临床医生在开出这些药物时面临的挑战，患者在生活中实施这些药物的使用时也面临着挑战。认识到这些挑战，领先的心血管学会在2014年为房颤高危患者的抗凝治疗个体化制定了共享决策(SDM)I类建议。然而，没有得到证实的干预措施来支持这一建议的实施，也没有证据表明SDM对启动和实施抗凝的问题产生了影响。凭借十多年的经验，我们已经展示了SDM干预在其他情况下的实际影响。基于这一经验，我们建议使用我们开发的SDM工具，该工具采用以用户为中心的设计，抗凝选择，在房颤患者和他们的临床医生之间推广关于抗凝的SDM。采用随机试验设计，我们计划确定使用该工具对SDM的质量、抗凝率和患者对该疗法的依从性的影响。通过产生可靠的基于实践的证据，这项试验可以向指南小组提供关于SDM对个性化抗凝护理质量的影响的反馈。我们建议纳入999名慢性非瓣膜性房颤患者，这些患者被认为是血栓栓塞性卒中的高危人群(CHA2DS2-VASC评分≥1分，女性为2分)，并在学术、社区或安全网诊所接受治疗。我们计划随机分配他们使用或不使用新的SDM工具，抗凝选择。试验结果包括SDM的质量(主要终点，目标1)、抗凝率、所选抗凝剂的分布，以及患者在12个月时坚持抗凝的情况(目标2)。如果成功，这项工作将减少抗凝治疗的使用不足，并改善数百万房颤患者的护理和预后。

 DESCRIPTION (provided by applicant): Chronic nonvalvular Atrial fibrillation (AF) is a very common and costly public health problem. AF may reduce the quality and duration of life, both, particularly by increasing the risk of devastating thromboembolic strokes. Anticoagulants, including vitamin K antagonists (VKAs, e.g., warfarin) and non-VKA anticoagulants (NOACs, e.g., dabigatran, -xabans), are very effective, but underused treatments. Anticoagulation underuse results form challenges clinicians face in prescribing these drugs and patients face in implementing their use in their lives. Recognizing these challenges, leading cardiovascular societies in 2014 formulated a class I recommendation of shared decision making (SDM) for the individualization of anticoagulation therapy in at-risk patients with AF. However, there are no proven interventions to support the implementation of this recommendation, and no evidence of the effect of SDM on the problem of initiating and implementing anticoagulation. With over a decade of experience, we have demonstrated the practical impact of SDM interventions in other contexts. Building on this experience, we propose to use an SDM tool we developed using user-centered design, ANTICOAGULATION CHOICE, to promote SDM about anticoagulation between patients with AF and their clinicians. Using a randomized trial design, we plan to determine the impact of using this tool on the quality of SDM and on the rate of anticoagulation and patient adherence to this therapy. By generating reliable practice-based evidence, this trial can provide feedback to the guideline panel about the impact of SDM on the quality of individualized anticoagulation care. We propose to enroll 999 adult patients with chronic nonvalvular AF deemed at high risk of thromboembolic strokes (CHA2DS2-VASc score ≥ 1, or 2 in women) and receiving care in academic, community, or safety net clinics. We plan to randomly assign them to care with or without a new SDM tool, ANTICOAGULATION CHOICE. Trial outcomes include the quality of SDM (primary endpoint, aim 1), the rate of anticoagulation, the distribution of anticoagulants chosen, and patient adherence to anticoagulation at 12 months (aim 2). If successful, this work will reduce the underuse of anticoagulation therapy and improve the care and outcomes of millions of patients with AF.